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FDA 510(k)

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

K-Number: K240457 · 2024-07-24

ApplicantPentax of America, Inc.
Decision Date2024-07-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K240457. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Pentax of America, Inc.. The 510(k) number is K240457.

When did C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) receive FDA 510(k) clearance?

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) received FDA 510(k) clearance on 2024-07-24, under 510(k) number K240457.

Who is the listed applicant for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)?

The FDA product code for C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) is GEH.

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Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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